|
Bextra FDA Warning
In November 2002, the U.S. Food and Drug Administration (FDA)
issued a warning about Bextra (valdecoxib). This warning comes
less than a year after the drug was approved. The FDA also
mandated product label changes for Bextra. Pfizer/Pharmicia,
the manufacturer of Bextra, sent letters to thousands of physicians
alerting them to the new warnings.
Bextra was approved by the FDA on November 2001 and went
to market in March 2002. It was approved for the relief of
the symptoms of osteoarthritis, adult rheumatoid arthritis,
and primary dysmennorhea.
The FDA has received about 20 reports of serious reactions
among Bextra users since sales began. Reactions include skin
diseases such as:
Other users have experienced hypersensitivity, including
anaphylactic reactions. The FDA estimates that over one million
people have taken the drug since it first went on sale.
Text of the Bextra Warnin
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01170.html
November 15, 2002
FDA and Pharmacia are advising health care professionals
about new warnings and information in the product labeling
of the drug Bextra (valdecoxib), a drug approved for treatment
of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual
pain). The labeling is being updated with new warnings following
postmarketing reports of serious adverse effects including
life-threatening risks related to skin reactions -- including
Stevens Johnson Syndrome, and anaphylactoid reactions (serious
allergic reactions). In addition, the labeling will state
that the drug is contraindicated -- not to be used -- in patients
allergic to sulfa containing products.
On November 13, 2002, Pharmacia, the manufacturer of Bextra
sent letters to health care professionals advising them of
postmarketing reports and new warnings that will be included
in the drug label. Since the firm began marketing the drug
in March of 2002, cases of the serious skin and hypersensitivity
reactions have been reported. These included cases of Stevens
Johnson syndrome, toxic epidermal necrolysis, exfoliative
dermatitis and erythema multiforme. Although these adverse
events are rare, some of these patients required hospitalization.
Based on these reports, FDA has approved labeling changes
for Bextra that include a warning for serious skin reactions.
As these reactions can be life threatening, people who start
Bextra and experience a rash should discontinue the drug immediately.
Bextra Warning
|
